Study to assess the bioequivalence between D961S and esomeprazole/buffered Acetylsalicylic Acid (ASA) in Japanese Healthy Male Subjects
Study identifier:D961SC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open label, Randomized, Single center, 2 way Crossover Bioequivalence Study Comparing D961S (a Fixed-dose Combination Capsule of Esomeprazole 20 mg and Acetylsalicylic Acid 81 mg) with a Free Combination of Esomeprazole Capsule 20 mg + Buffered Acetylsalicylic Acid Tablet 81 mg After Repeated Oral Administration in Japanese Healthy Male Subjects
Medical condition
Bioequivalence study
Phase
Phase 1
Healthy volunteers
Yes
Study drug
D961S, Esomeprazole, Buffered acetylsalicylic acid
Sex
Male
Actual Enrollment
77
Study type
Interventional
Age
20 Years - 45 Years
Date
Study Start Date: 01 Jan 2012
Primary Completion Date: 01 Mar 2012
Study Completion Date: 01 Mar 2012
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: D961S 2 way crossover | Drug: D961S Oral gelatine capsule |
| Experimental: esomeprazole + buffered acetylsalicylic acid 2 way crossover | Drug: Esomeprazole Oral HPMC capsule Other Name: Nexium® capsule 20 mg Drug: Buffered acetylsalicylic acid Tablet Other Name: Bufferin Combination Tablet A81 |
